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Two Morgan Lewis attorneys explain a new FDA draft guidance on three-year drug exclusivity for new clinical investigations.[ Price : $8.95]
Senate appropriators delay consideration of a fiscal 2027 spending bill that would fund FDA, after a broader dispute over a Republ...[ Price : $8.95]
FDA has accepted a Letter of Intent for the first in silico artificial intelligence-driven digital liver model for predicting drug...[ Price : $8.95]
FDA accepts for priority review a Roche NDA for giredestrant, an investigational oral endocrine therapy for patients with early-st...[ Price : $8.95]
FDA issues Cingulate a complete response letter on the company's NDA for CTx-1301, an investigational treatment for attention-defi...[ Price : $8.95]
FDA issues an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with t...[ Price : $8.95]
FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.[ Price : $8.95]
FDA warns Mexicos Laboratorios Jaloma about CGMP violations in its production of finished drugs.